Trial Outcomes & Findings for Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma (NCT NCT02401542)

Last Updated: 2020-03-09

Results Overview

Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by PFS; measured from randomization to first occurrence of disease progression (per RECIST v1.1) or death, whichever occurs first. A patient has had to receive at least one vofatamab dose. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

71 participants

Primary outcome timeframe

3-4 years

Results posted on

2020-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	Vofatamab Plus Docetaxel IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor. Vofatamab Docetaxel	Vofatamab IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Vofatamab
Overall Study STARTED	41	30
Overall Study COMPLETED	40	30
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vofatamab Plus Docetaxel n=40 Participants IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor. Vofatamab Docetaxel	Vofatamab n=30 Participants IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Vofatamab	Placebo Plus Docetaxel IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle. One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor Docetaxel Placebo	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	32 Participants n=4 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	18 Participants n=7 Participants	0 Participants n=5 Participants	38 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	24 Participants n=7 Participants	0 Participants n=5 Participants	57 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	18 Participants n=7 Participants	0 Participants n=5 Participants	54 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3-4 years

Outcome measures

Outcome measures
Measure	Mut/Fus Phase 1 n=6 Participants Vofatamab plus Docetaxel	Wild Type Phase 1 n=13 Participants Vofatamab plus Docetaxel	Mut/Fus Phase 2 n=21 Participants Vofatamab plus Docetaxel	Mut/Fus Phase 2 Monotherapy n=21 Participants Vofatamab Monotherpay	Mut/Fus Phase 2b Monotherapy n=9 Participants Vofatamab Monotherapy
Primary Efficacy Outcome: Progression Free Survival (PFS)	6.82 Months Standard Deviation 5.35	2.83 Months Standard Deviation 2.73	4.40 Months Standard Deviation 4.15	4.45 Months Standard Deviation 3.27	2.23 Months Standard Deviation 1.45

Adverse Events

Vofatamab Plus Docetaxel

Serious events: 21 serious events

Other events: 40 other events

Deaths: 2 deaths

Vofatamab

Serious events: 6 serious events

Other events: 30 other events

Deaths: 1 deaths

Placebo Plus Docetaxel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Rainier Therapeutics

Phone: 510-878-2486

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Vofatamab Plus Docetaxel n=40 participants at risk IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor. Vofatamab Docetaxel	Vofatamab n=30 participants at risk IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Vofatamab	Placebo Plus Docetaxel IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle. One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor Docetaxel Placebo
Infections and infestations Pneumonia	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Infections and infestations Sepsis	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Infections and infestations Urinary Tract Infection	0.00% 0/40 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	6.7% 2/30 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Infections and infestations Clostridium difficile infection	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Infections and infestations Neutropenic infection	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Vomiting	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Abdominal pain	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Anal incontinence	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Constipation	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Large intestinal obstruction	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Pancreatitis	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Rectal haemorrhage	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
General disorders Pain	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
General disorders Chills	0.00% 0/40 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
General disorders Fatigue	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
General disorders Mucosal inflammation	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
General disorders Non-cardiac chest pain	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
General disorders Pyrexia	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Blood and lymphatic system disorders Febrile Neutropenia	7.5% 3/40 • Number of events 3 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Blood and lymphatic system disorders Neutropenia	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Blood and lymphatic system disorders Disseminated intravascular coagulation	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Blood and lymphatic system disorders Thrombocytopenia	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Injury, poisoning and procedural complications Infusion related reaction	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Injury, poisoning and procedural complications Overdose	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Injury, poisoning and procedural complications Spinal compression fracture	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Injury, poisoning and procedural complications Urinary tract stoma complication	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Cardiac disorders Atrial fibrillation	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Cardiac disorders Cyanosis	0.00% 0/40 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Cardiac disorders Myocardial infarction	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Renal and urinary disorders Haematuria	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Renal and urinary disorders Renal failure	0.00% 0/40 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Renal and urinary disorders Urinary incontinence	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/40 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Vascular disorders Deep vein thrombosis	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Vascular disorders Hypertension	0.00% 0/40 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Vascular disorders Hypotension	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.

Other adverse events
Measure	Vofatamab Plus Docetaxel n=40 participants at risk IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor. Vofatamab Docetaxel	Vofatamab n=30 participants at risk IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Vofatamab	Placebo Plus Docetaxel IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle. One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor Docetaxel Placebo
Gastrointestinal disorders Right lower quadrant pain	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
General disorders Rigors	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Ear and labyrinth disorders Ringing in ears	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Nervous system disorders Sensory neuropathy	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Investigations SGOT increased	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
General disorders Shivers	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Respiratory, thoracic and mediastinal disorders Shortness of breath	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Musculoskeletal and connective tissue disorders Shoulder pain	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Respiratory, thoracic and mediastinal disorders Sinus congestion	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Cardiac disorders Sinus tachycardia	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Infections and infestations Sinusitis	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Skin and subcutaneous tissue disorders Skin disorder	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Injury, poisoning and procedural complications Skin laceration	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Skin and subcutaneous tissue disorders Skin peeling	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Skin and subcutaneous tissue disorders Skin rash	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Skin and subcutaneous tissue disorders Skin ulcer bleeding	0.00% 0/40 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Abdominal pain	22.5% 9/40 • Number of events 9 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Abdominal tenderness	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Investigations Abnormal ECG	0.00% 0/40 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Investigations Absolute neutrophil count decreased	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
General disorders Ache	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Injury, poisoning and procedural complications Achilles tendon injury	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Investigations Activated partial thromboplastin time prolonged	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Renal and urinary disorders Acute kidney injury	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Psychiatric disorders Adjustment disorder	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Gastrointestinal disorders Aerophagia	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Respiratory, thoracic and mediastinal disorders Airway compromise	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Investigations Alkaline phosphatase increased	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Skin and subcutaneous tissue disorders Alopecia	27.5% 11/40 • Number of events 11 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Investigations ALP increased	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Investigations ALT increased	10.0% 4/40 • Number of events 4 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Blood and lymphatic system disorders Anemia	27.5% 11/40 • Number of events 11 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	6.7% 2/30 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Blood and lymphatic system disorders Anemia aggravated	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Injury, poisoning and procedural complications Ankle sprain	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Metabolism and nutrition disorders Anorexia	25.0% 10/40 • Number of events 10 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	6.7% 2/30 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Psychiatric disorders Anxiety	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Psychiatric disorders Anxiety aggravated	2.5% 1/40 • Number of events 1 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Metabolism and nutrition disorders Appetite lost	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 2/40 • Number of events 2 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	0.00% 0/30 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.	— 0/0 • Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug. Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.