Trial Outcomes & Findings for Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors (NCT NCT01803282)

NCT ID: NCT01803282

Last Updated: 2020-06-02

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

236 participants

Primary outcome timeframe

Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days

Results posted on

2020-06-02

Participant Flow

Participants were enrolled at study sites in the United States. The first participant was screened on 29 March 2013. The last study visit occurred on 23 April 2019.

280 participants were screened.

Participant milestones

Participant milestones
Measure
Part A: ADX 200 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg andecaliximab (ADX) as monotherapy via intravenous (IV) infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 600 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 1800 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: PAC, ADX 800 mg
Participants with pancreatic adenocarcinoma (PAC) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LAC, ADX 1200 mg
Participants with lung adenocarcinoma (LAC) received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LSC, ADX 1200 mg
Participants with lung squamous cell carcinoma (LSC) received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: EGC, ADX 800 mg
Participants with esophagogastric adenocarcinoma (EGC) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+oxaliplatin+5-fluorouracil {5-FU} \[mFOLFOX6\], on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with colorectal cancer (CRC) received first-line (FL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received second-line (SL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+irinotecan+5-FU \[FOLFIRI\] and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: BRCA, ADX 800 mg
Participants with breast cancer (BRCA) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Overall Study
STARTED
4
3
6
36
11
10
41
46
11
45
8
15
Overall Study
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
Overall Study
NOT COMPLETED
4
3
6
36
11
10
41
46
11
45
8
15

Reasons for withdrawal

Reasons for withdrawal
Measure
Part A: ADX 200 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg andecaliximab (ADX) as monotherapy via intravenous (IV) infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 600 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 1800 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: PAC, ADX 800 mg
Participants with pancreatic adenocarcinoma (PAC) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LAC, ADX 1200 mg
Participants with lung adenocarcinoma (LAC) received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LSC, ADX 1200 mg
Participants with lung squamous cell carcinoma (LSC) received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: EGC, ADX 800 mg
Participants with esophagogastric adenocarcinoma (EGC) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+oxaliplatin+5-fluorouracil {5-FU} \[mFOLFOX6\], on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with colorectal cancer (CRC) received first-line (FL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received second-line (SL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+irinotecan+5-FU \[FOLFIRI\] and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: BRCA, ADX 800 mg
Participants with breast cancer (BRCA) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Overall Study
Progressive Disease
4
3
6
22
5
8
23
24
3
29
6
11
Overall Study
Death
0
0
0
0
2
1
1
5
1
1
0
0
Overall Study
Withdrew Consent
0
0
0
6
1
0
8
3
1
5
0
1
Overall Study
Investigator's Discretion
0
0
0
7
2
1
7
10
6
7
1
0
Overall Study
Adverse Event
0
0
0
0
0
0
1
2
0
1
0
3
Overall Study
Non-Compliance with Study Drug
0
0
0
1
0
0
0
0
0
0
0
0
Overall Study
Unknown Reason
0
0
0
0
0
0
0
1
0
0
0
0
Overall Study
Specified Criteria for Withdrawal
0
0
0
0
0
0
0
0
0
1
1
0
Overall Study
Enrolled but Never Treated
0
0
0
0
1
0
1
1
0
1
0
0

Baseline Characteristics

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part A: ADX 200 mg
n=4 Participants
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 600 mg
n=3 Participants
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 1800 mg
n=6 Participants
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: PAC, ADX 800 mg
n=36 Participants
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LAC, ADX 1200 mg
n=10 Participants
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LSC, ADX 1200 mg
n=10 Participants
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: EGC, ADX 800 mg
n=40 Participants
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
n=45 Participants
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
n=11 Participants
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
n=44 Participants
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
n=8 Participants
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: BRCA, ADX 800 mg
n=15 Participants
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Total
n=232 Participants
Total of all reporting groups
Age, Customized
Age · < 65 years
2 Participants
n=5 Participants
0 Participants
n=7 Participants
4 Participants
n=5 Participants
15 Participants
n=4 Participants
2 Participants
n=21 Participants
4 Participants
n=8 Participants
25 Participants
n=8 Participants
26 Participants
n=24 Participants
8 Participants
n=42 Participants
33 Participants
n=42 Participants
4 Participants
n=42 Participants
10 Participants
n=42 Participants
133 Participants
n=36 Participants
Age, Customized
Age · ≥ 65 years
2 Participants
n=5 Participants
3 Participants
n=7 Participants
2 Participants
n=5 Participants
21 Participants
n=4 Participants
8 Participants
n=21 Participants
6 Participants
n=8 Participants
15 Participants
n=8 Participants
19 Participants
n=24 Participants
3 Participants
n=42 Participants
11 Participants
n=42 Participants
4 Participants
n=42 Participants
5 Participants
n=42 Participants
99 Participants
n=36 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
10 Participants
n=4 Participants
7 Participants
n=21 Participants
4 Participants
n=8 Participants
9 Participants
n=8 Participants
19 Participants
n=24 Participants
3 Participants
n=42 Participants
25 Participants
n=42 Participants
2 Participants
n=42 Participants
13 Participants
n=42 Participants
95 Participants
n=36 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
26 Participants
n=4 Participants
3 Participants
n=21 Participants
6 Participants
n=8 Participants
31 Participants
n=8 Participants
26 Participants
n=24 Participants
8 Participants
n=42 Participants
19 Participants
n=42 Participants
6 Participants
n=42 Participants
2 Participants
n=42 Participants
137 Participants
n=36 Participants
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
4 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
4 Participants
n=8 Participants
4 Participants
n=24 Participants
0 Participants
n=42 Participants
4 Participants
n=42 Participants
0 Participants
n=42 Participants
2 Participants
n=42 Participants
19 Participants
n=36 Participants
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
4 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
32 Participants
n=4 Participants
10 Participants
n=21 Participants
9 Participants
n=8 Participants
30 Participants
n=8 Participants
39 Participants
n=24 Participants
10 Participants
n=42 Participants
39 Participants
n=42 Participants
8 Participants
n=42 Participants
12 Participants
n=42 Participants
202 Participants
n=36 Participants
Race/Ethnicity, Customized
Ethnicity · Not Permitted
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
6 Participants
n=8 Participants
2 Participants
n=24 Participants
1 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
11 Participants
n=36 Participants
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
3 Participants
n=36 Participants
Race/Ethnicity, Customized
Race · Asian
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
1 Participants
n=8 Participants
1 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
2 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
4 Participants
n=36 Participants
Race/Ethnicity, Customized
Race · Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=8 Participants
1 Participants
n=8 Participants
6 Participants
n=24 Participants
2 Participants
n=42 Participants
2 Participants
n=42 Participants
1 Participants
n=42 Participants
1 Participants
n=42 Participants
18 Participants
n=36 Participants
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
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
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
Race/Ethnicity, Customized
Race · White
3 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
33 Participants
n=4 Participants
9 Participants
n=21 Participants
5 Participants
n=8 Participants
31 Participants
n=8 Participants
35 Participants
n=24 Participants
8 Participants
n=42 Participants
35 Participants
n=42 Participants
6 Participants
n=42 Participants
12 Participants
n=42 Participants
185 Participants
n=36 Participants
Race/Ethnicity, Customized
Race · Not Permitted
1 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
6 Participants
n=8 Participants
3 Participants
n=24 Participants
0 Participants
n=42 Participants
2 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
13 Participants
n=36 Participants
Race/Ethnicity, Customized
Race · Other
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=24 Participants
1 Participants
n=42 Participants
2 Participants
n=42 Participants
1 Participants
n=42 Participants
1 Participants
n=42 Participants
9 Participants
n=36 Participants

PRIMARY outcome

Timeframe: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days

Population: The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).

Outcome measures

Outcome measures
Measure
Part A: ADX 200 mg
n=4 Participants
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 600 mg
n=3 Participants
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 1800 mg
n=6 Participants
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: PAC, ADX 800 mg
n=36 Participants
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LAC, ADX 1200 mg
n=10 Participants
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LSC, ADX 1200 mg
n=10 Participants
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: EGC, ADX 800 mg
n=40 Participants
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
n=45 Participants
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
n=11 Participants
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
n=44 Participants
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
n=8 Participants
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: BRCA, ADX 800 mg
n=15 Participants
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
100.0 percentage of participants
100.0 percentage of participants
83.3 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants

PRIMARY outcome

Timeframe: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days

Population: Participants in the Safety Analysis Set were analyzed.

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.

Outcome measures

Outcome measures
Measure
Part A: ADX 200 mg
n=4 Participants
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 600 mg
n=3 Participants
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 1800 mg
n=6 Participants
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: PAC, ADX 800 mg
n=36 Participants
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LAC, ADX 1200 mg
n=10 Participants
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LSC, ADX 1200 mg
n=10 Participants
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: EGC, ADX 800 mg
n=40 Participants
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
n=45 Participants
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
n=11 Participants
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
n=44 Participants
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
n=8 Participants
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: BRCA, ADX 800 mg
n=15 Participants
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Percentage of Participants Experiencing Laboratory Abnormalities
Any Laboratory abnormalities: Hematology
0.0 percentage of participants
33.3 percentage of participants
33.3 percentage of participants
97.2 percentage of participants
90.0 percentage of participants
80.0 percentage of participants
87.5 percentage of participants
84.4 percentage of participants
90.9 percentage of participants
95.5 percentage of participants
100.0 percentage of participants
86.7 percentage of participants
Percentage of Participants Experiencing Laboratory Abnormalities
Any Laboratory abnormalities: Serum Chemistry
100.0 percentage of participants
66.7 percentage of participants
83.3 percentage of participants
88.9 percentage of participants
60.0 percentage of participants
70.0 percentage of participants
87.5 percentage of participants
95.6 percentage of participants
81.8 percentage of participants
86.4 percentage of participants
87.5 percentage of participants
66.7 percentage of participants
Percentage of Participants Experiencing Laboratory Abnormalities
Any Laboratory abnormalities: Coagulation
25.0 percentage of participants
0.0 percentage of participants
33.3 percentage of participants
38.9 percentage of participants
10.0 percentage of participants
10.0 percentage of participants
35.0 percentage of participants
37.8 percentage of participants
36.4 percentage of participants
45.5 percentage of participants
37.5 percentage of participants
40.0 percentage of participants

Adverse Events

Part A: ADX 200 mg

Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths

Part A: ADX 600 mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part A: ADX 1800 mg

Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths

Part B: PAC, ADX 800 mg

Serious events: 19 serious events
Other events: 36 other events
Deaths: 8 deaths

Part B: LAC, ADX 1200 mg

Serious events: 5 serious events
Other events: 9 other events
Deaths: 4 deaths

Part B: LSC, ADX 1200 mg

Serious events: 6 serious events
Other events: 10 other events
Deaths: 3 deaths

Part B: EGC, ADX 800 mg

Serious events: 19 serious events
Other events: 40 other events
Deaths: 13 deaths

Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg

Serious events: 17 serious events
Other events: 45 other events
Deaths: 22 deaths

Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg

Serious events: 3 serious events
Other events: 11 other events
Deaths: 5 deaths

Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg

Serious events: 13 serious events
Other events: 44 other events
Deaths: 25 deaths

Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg

Serious events: 4 serious events
Other events: 8 other events
Deaths: 5 deaths

Part B: BRCA, ADX 800 mg

Serious events: 5 serious events
Other events: 15 other events
Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure
Part A: ADX 200 mg
n=4 participants at risk
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 600 mg
n=3 participants at risk
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 1800 mg
n=6 participants at risk
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: PAC, ADX 800 mg
n=36 participants at risk
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LAC, ADX 1200 mg
n=10 participants at risk
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LSC, ADX 1200 mg
n=10 participants at risk
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: EGC, ADX 800 mg
n=40 participants at risk
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
n=45 participants at risk
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
n=11 participants at risk
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
n=44 participants at risk
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
n=8 participants at risk
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: BRCA, ADX 800 mg
n=15 participants at risk
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Blood and lymphatic system disorders
Anaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Neutropenia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Acute coronary syndrome
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Acute myocardial infarction
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Atrial fibrillation
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Atrial flutter
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Cardiac arrest
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Pericardial effusion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Endocrine disorders
Adrenal haemorrhage
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Eye disorders
Eyelid ptosis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Abdominal distension
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Abdominal pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Ascites
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Colitis ischaemic
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Constipation
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Diarrhoea
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Duodenal obstruction
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Duodenal perforation
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Dysphagia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Enteritis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Gastric haemorrhage
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Haematemesis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Ileus
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Large intestinal obstruction
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Nausea
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Obstruction gastric
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Oesophageal haemorrhage
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Proctalgia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Vomiting
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Catheter site extravasation
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Catheter site haematoma
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Chest pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Fatigue
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Performance status decreased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Pyrexia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.9%
5/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Hepatobiliary disorders
Hepatic failure
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Abdominal abscess
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Bacteraemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Cellulitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Cellulitis of male external genital organ
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Cystitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Escherichia pyelonephritis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Gangrene
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Influenza
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Large intestine infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Peritonitis bacterial
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Pneumonia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Pneumonia streptococcal
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Pyelonephritis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Rotavirus infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Sepsis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Septic shock
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Skin infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Urinary tract infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Urosepsis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Carbon monoxide poisoning
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Fall
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Ligament sprain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Post procedural complication
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Anticoagulation drug level above therapeutic
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Dehydration
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Failure to thrive
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Fluid overload
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Cerebrovascular accident
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Haemorrhage intracranial
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Hypoaesthesia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Transient ischaemic attack
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Tremor
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Unresponsive to stimuli
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Psychiatric disorders
Anxiety
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Psychiatric disorders
Confusional state
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Psychiatric disorders
Mental status changes
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Acute kidney injury
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Haematuria
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Hydronephrosis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Nephrolithiasis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Urinary retention
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Urinary tract obstruction
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Diabetic foot
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Rash
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Deep vein thrombosis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Embolism
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Haematoma
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Shock haemorrhagic
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).

Other adverse events

Other adverse events
Measure
Part A: ADX 200 mg
n=4 participants at risk
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 600 mg
n=3 participants at risk
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part A: ADX 1800 mg
n=6 participants at risk
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: PAC, ADX 800 mg
n=36 participants at risk
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LAC, ADX 1200 mg
n=10 participants at risk
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: LSC, ADX 1200 mg
n=10 participants at risk
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: EGC, ADX 800 mg
n=40 participants at risk
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
n=45 participants at risk
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
n=11 participants at risk
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
n=44 participants at risk
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
n=8 participants at risk
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Part B: BRCA, ADX 800 mg
n=15 participants at risk
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
General disorders
Temperature intolerance
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
12/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
37.8%
17/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hypoproteinaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Constipation
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
19.4%
7/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
40.0%
4/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
35.0%
14/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
37.8%
17/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.3%
3/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.3%
12/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
62.5%
5/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
46.7%
7/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Bradycardia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Anaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.6%
11/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
70.0%
7/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
12/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
9/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
11/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
3/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Hypercoagulation
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Leukopenia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Neutropenia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
12/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
40.0%
4/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
40.0%
16/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
40.0%
18/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
45.5%
5/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.3%
12/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
62.5%
5/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
40.0%
6/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.8%
10/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
3/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
3/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
8/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Angina pectoris
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Atrial fibrillation
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Palpitations
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Sinus tachycardia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Cardiac disorders
Tachycardia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Ear and labyrinth disorders
Ear pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Ear and labyrinth disorders
Tinnitus
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Ear and labyrinth disorders
Vertigo
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Eye disorders
Conjunctival oedema
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Eye disorders
Dry eye
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Eye disorders
Erythema of eyelid
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Eye disorders
Eye swelling
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Eye disorders
Lacrimation increased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Eye disorders
Ocular hyperaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Eye disorders
Photopsia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Eye disorders
Vision blurred
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Abdominal distension
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Abdominal pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
6/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
5/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
26.7%
12/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
11/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
62.5%
5/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
3/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Abdominal wall haematoma
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Anorectal discomfort
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Ascites
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Colitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Dental caries
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Diarrhoea
50.0%
2/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
44.4%
16/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
40.0%
4/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
47.5%
19/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
55.6%
25/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.3%
3/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
63.6%
28/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
75.0%
6/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
5/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Dry mouth
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.0%
6/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Dyschezia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Dyspepsia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Dysphagia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
5/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Erosive oesophagitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Swelling
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Flatulence
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Gingival bleeding
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Haematochezia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Haemorrhoids
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Mouth ulceration
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Nausea
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
66.7%
2/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
2/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
50.0%
18/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
3/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
50.0%
5/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
62.5%
25/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
73.3%
33/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
81.8%
9/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
61.4%
27/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
62.5%
5/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
40.0%
6/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Oral pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Proctalgia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.6%
6/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Rectal fissure
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Stomatitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
17.5%
7/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
24.4%
11/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
34.1%
15/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
50.0%
4/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Toothache
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Gastrointestinal disorders
Vomiting
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
2/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
9/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
32.5%
13/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
31.1%
14/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
45.5%
5/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
31.8%
14/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
37.5%
3/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Asthenia
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
1/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
6/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
17.8%
8/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.6%
6/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
62.5%
5/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Axillary pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Catheter site pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Chest discomfort
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Chest pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Chills
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Complication associated with device
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Early satiety
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Fatigue
50.0%
2/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
66.7%
2/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
75.0%
27/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
50.0%
5/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
70.0%
7/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
57.5%
23/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
80.0%
36/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
63.6%
7/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
59.1%
26/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
75.0%
6/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
73.3%
11/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Gait disturbance
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Generalised oedema
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Influenza like illness
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Malaise
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Mucosal inflammation
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
5/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
17.8%
8/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.5%
9/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Non-cardiac chest pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Oedema peripheral
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
55.6%
20/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.5%
11/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.9%
5/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Peripheral swelling
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
General disorders
Pyrexia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
22.2%
8/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.0%
6/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
8/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Hepatobiliary disorders
Cholecystitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Hepatobiliary disorders
Hepatic cirrhosis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Immune system disorders
Drug hypersensitivity
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Immune system disorders
Hypersensitivity
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Immune system disorders
Seasonal allergy
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Abscess
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
1/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Bacteraemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Candida infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Cellulitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
1/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
4/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Cystitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Ear infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Eye infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Gastroenteritis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Gastrointestinal infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Hepatitis C
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Herpes zoster
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Hordeolum
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Infected cyst
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Laryngitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Lung infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Nail infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Nasopharyngitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Oral candidiasis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Pneumonia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Pyuria
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Sinusitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Upper respiratory tract infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
5/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.3%
3/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Urinary tract infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
4/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
6/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
8/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Infections and infestations
Wound infection
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Arthropod bite
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Contusion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Fall
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
5/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.6%
7/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.6%
6/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Injection related reaction
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Limb injury
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Stoma complication
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Injury, poisoning and procedural complications
Wound dehiscence
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Alanine aminotransferase increased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
3/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Aspartate aminotransferase increased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
1/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
6/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
3/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Blood alkaline phosphatase increased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Blood bilirubin increased
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Blood creatinine increased
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Carcinoembryonic antigen increased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Haemoglobin decreased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Heart rate irregular
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
International normalised ratio increased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Liver function test increased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Lymphocyte count decreased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Neutrophil count decreased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
6/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
17.5%
7/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
22.2%
10/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.5%
9/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Platelet count decreased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
4/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
17.5%
7/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.4%
5/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Prothrombin time prolonged
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Weight decreased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
19.4%
7/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
5/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.6%
7/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
Weight increased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Investigations
White blood cell count decreased
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
5/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.6%
6/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.8%
10/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
12/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
42.2%
19/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.3%
3/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.5%
9/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
3/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Dehydration
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
17.5%
7/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
26.7%
12/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.5%
9/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
26.7%
4/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Fluid overload
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Folate deficiency
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
4/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hypokalaemia
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
22.2%
8/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
9/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.3%
3/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
8/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
50.0%
4/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.4%
5/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Metabolism and nutrition disorders
Malnutrition
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
1/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
3/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.0%
6/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
22.2%
10/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
8/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
3/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
17.5%
7/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
9/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Joint stiffness
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
17.8%
8/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
19.4%
7/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
3/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.4%
5/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
22.2%
8/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
5/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Pathological fracture
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Musculoskeletal and connective tissue disorders
Spondylitis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Tremor
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Amnesia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
1/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Ataxia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Balance disorder
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Dizziness
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
1/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
19.4%
7/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.0%
6/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.6%
7/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
11/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Dysaesthesia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.3%
3/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Dysgeusia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.8%
10/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
8/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
6/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
3/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Facial paralysis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Headache
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.9%
5/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.0%
6/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
28.9%
13/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
8/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Hypoaesthesia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Loss of consciousness
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Memory impairment
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Movement disorder
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Neuralgia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Neuropathy peripheral
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
1/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.6%
11/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
40.0%
4/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
47.5%
19/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
35.6%
16/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
36.4%
4/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
5/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Paraesthesia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
22.2%
8/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
22.5%
9/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
35.6%
16/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
48.9%
22/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
27.3%
3/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Presyncope
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Sciatica
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Seizure
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Somnolence
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Syncope
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Taste disorder
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Toxic encephalopathy
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Nervous system disorders
Vocal cord paralysis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Psychiatric disorders
Agitation
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Psychiatric disorders
Anxiety
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
6/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
5/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Psychiatric disorders
Confusional state
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Psychiatric disorders
Delirium
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Psychiatric disorders
Depression
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
4/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.0%
6/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
37.5%
3/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Psychiatric disorders
Insomnia
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
10/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
17.8%
8/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Dysuria
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Haematuria
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
7.5%
3/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.4%
5/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Nephrolithiasis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Pollakiuria
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Proteinuria
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
24.4%
11/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.4%
5/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Ureterolithiasis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Urinary incontinence
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Renal and urinary disorders
Urinary retention
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Cough
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
2/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.6%
11/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.0%
6/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
9/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.6%
6/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
26.7%
4/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
3/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
50.0%
3/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
19.4%
7/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.0%
6/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
26.7%
12/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.4%
5/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
33.3%
5/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
3/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Emphysema
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
4/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.6%
7/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.5%
9/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Haemoptysis
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
30.0%
3/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
6/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Nasal dryness
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.6%
2/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
6/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.3%
2/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Respiratory, thoracic and mediastinal disorders
Throat tightness
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
55.6%
20/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
50.0%
5/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
4/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
34.1%
15/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
2/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
60.0%
9/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
22.2%
8/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
5/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Granuloma annulare
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.9%
4/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Nail discolouration
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Nail ridging
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
16.7%
1/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
15.0%
6/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Rash
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
25.0%
9/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
8/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Rash generalised
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.5%
1/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
12.5%
1/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Skin discolouration
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.8%
1/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
3/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Aortic intramural haematoma
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Deep vein thrombosis
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
13.9%
5/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.3%
1/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Embolism
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Flushing
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.5%
2/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.7%
1/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Haematoma
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
2.2%
1/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Hot flush
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
6.8%
3/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Hypertension
25.0%
1/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
8.3%
3/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
40.0%
18/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
18.2%
2/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.4%
5/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Hypotension
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
11.1%
4/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
20.0%
2/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
5.0%
2/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
4.4%
2/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
1/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
9.1%
4/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Vascular disorders
Peripheral coldness
0.00%
0/4 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/3 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/6 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/36 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
10.0%
1/10 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/40 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/45 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/11 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/44 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/8 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
0.00%
0/15 • Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Results disclosure agreements

  • Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
  • Publication restrictions are in place

Restriction type: OTHER