Trial Outcomes & Findings for AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) (NCT NCT05780437)

Last Updated: 2025-02-04

Results Overview

The primary endpoint is the proportion of subjects with sustained recovery, which is defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90. Home is defined as the level of residence or facility where the participant was residing prior to hospital admission leading to enrollment in this protocol. Readmission from "home" may occur, and if this occurs within 14 days of the first discharge to "home," then the primary endpoint will not be reached until such time as the participant has been at home for 14 consecutive days.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1455 participants

Primary outcome timeframe

Through Day 90

Results posted on

2025-02-04

Participant Flow

Subjects were enrolled from 81 sites in 8 countries (Denmark, Poland, Singapore, Spain, Switzerland, Uganda, UK, USA). The first subject was enrolled on 10 Feb 2021 and the last subject was enrolled on 30 Sep 2021.

The number of participants consented was not collected, so these numbers are the number of participants randomized.

Participant milestones

Participant milestones
Measure	AZD7442 Plus SOC * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
Overall Study STARTED	732	723
Overall Study COMPLETED	710	707
Overall Study NOT COMPLETED	22	16

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD7442 Plus SOC * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
Overall Study Withdrawal by Subject	22	16

Baseline Characteristics

AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD7442 Plus SOC n=710 Participants * AZD7442 600 mg solution (separate vials containing 300 mg each of AZD88995 and AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC n=707 Participants * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent	Total n=1417 Participants Total of all reporting groups
Age, Continuous	55.2 years STANDARD_DEVIATION 14.7 • n=99 Participants	55.0 years STANDARD_DEVIATION 15.0 • n=107 Participants	55.1 years STANDARD_DEVIATION 14.8 • n=206 Participants
Sex: Female, Male Female	299 Participants n=99 Participants	295 Participants n=107 Participants	594 Participants n=206 Participants
Sex: Female, Male Male	411 Participants n=99 Participants	412 Participants n=107 Participants	823 Participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Race/Ethnicity, Customized Asian	33 Participants n=99 Participants	24 Participants n=107 Participants	57 Participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	3 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	175 Participants n=99 Participants	172 Participants n=107 Participants	347 Participants n=206 Participants
Race/Ethnicity, Customized White	413 Participants n=99 Participants	395 Participants n=107 Participants	808 Participants n=206 Participants
Race/Ethnicity, Customized More than one race	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Race/Ethnicity, Customized Other	15 Participants n=99 Participants	21 Participants n=107 Participants	36 Participants n=206 Participants
Race/Ethnicity, Customized Only ethnicity reported	67 Participants n=99 Participants	83 Participants n=107 Participants	150 Participants n=206 Participants

PRIMARY outcome

Timeframe: Through Day 90

Outcome measures

Outcome measures
Measure	AZD7442 Plus SOC n=710 Participants * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC n=707 Participants * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
Number of Participants With Sustained Recovery	617 Participants	594 Participants

PRIMARY outcome

Timeframe: Status on Day 5

Ordinal outcome with 7 mutually exclusive categories

Outcome measures

Outcome measures
Measure	AZD7442 Plus SOC n=695 Participants * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC n=689 Participants * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
Number of Participants With an Ordinal Outcome on Day 5 5 = Non-invasive ventilation or high flow oxygen	102 Participants	99 Participants
Number of Participants With an Ordinal Outcome on Day 5 1 = No limiting symptoms due to COVID-19	117 Participants	117 Participants
Number of Participants With an Ordinal Outcome on Day 5 7 = Death	10 Participants	13 Participants
Number of Participants With an Ordinal Outcome on Day 5 6 = Invasive ventilation, ECMO, mechanical circulatory support, new renal replacement therapy	32 Participants	29 Participants
Number of Participants With an Ordinal Outcome on Day 5 4 = Supplement oxgen (≥4 L/min or ≥4 L/min above baseline, but not high flow oxygen)	92 Participants	106 Participants
Number of Participants With an Ordinal Outcome on Day 5 3 = Supplement oxgen (<4 L/min or <4 L/min above baseline, but not high flow oxygen)	127 Participants	126 Participants
Number of Participants With an Ordinal Outcome on Day 5 2 = Limiting symptoms due to COVID-19, but no need of new or increased oxygen from baseline	215 Participants	199 Participants

SECONDARY outcome

Timeframe: Through Day 5

Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5. Seriousness was based on the definition of the term at 21CFR312.32 AEs were graded for severity by the treating investigator, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table), U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. \[July 2017\]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf). The following generic grading descriptions from the DAIDS AE Grading Table are provided for context: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening

Outcome measures

Outcome measures
Measure	AZD7442 Plus SOC n=710 Participants * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC n=707 Participants * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
Number of Participants With a Safety Outcome Through Day 5	181 Participants	202 Participants

SECONDARY outcome

Timeframe: Through Day 28

Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28. Seriousness was based on the definition of the term at 21CFR312.32 AEs were graded for severity by the treating investigator, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table), U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. \[July 2017\]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf). The following generic grading descriptions from the DAIDS AE Grading Table are provided for context: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening

Outcome measures

Outcome measures
Measure	AZD7442 Plus SOC n=710 Participants * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC n=707 Participants * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
Number of Participants With a Safety Outcome Through Day 28	226 Participants	250 Participants

SECONDARY outcome

Timeframe: Through Day 90

Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 90. Seriousness was based on the definition of the term at 21CFR312.32 AEs were graded for severity according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table).

Outcome measures

Outcome measures
Measure	AZD7442 Plus SOC n=710 Participants * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC n=707 Participants * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
Number of Participants With a Safety Outcome Through Day 90	179 Participants	214 Participants

SECONDARY outcome

Timeframe: Through Day 90

All-cause Mortality

Outcome measures

Outcome measures
Measure	AZD7442 Plus SOC n=710 Participants * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC n=707 Participants * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
Number of Participants Who Died From All Causes	61 Participants	86 Participants

Adverse Events

AZD7442 Plus SOC

Serious events: 36 serious events

Other events: 176 other events

Deaths: 61 deaths

Placebo Plus SOC

Serious events: 39 serious events

Other events: 184 other events

Deaths: 86 deaths

Serious adverse events

Other adverse events

Additional Information

Greg Grandits

University of Minnesota

Phone: 651-528-9491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	AZD7442 Plus SOC n=710 participants at risk * AZD7442 600 mg solution (separate vials containing 300 mg each of AZD88995 and AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	Placebo Plus SOC n=707 participants at risk * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
Blood and lymphatic system disorders Anemia	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.28% 2/707 • Number of events 2 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Blood and lymphatic system disorders Anemia of chronic disease	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Blood and lymphatic system disorders Normocytic anemia	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Blood and lymphatic system disorders Pancytopenia	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Cardiac disorders Acute myocardial infarction	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Cardiac disorders Angina pectoris	0.14% 1/710 • Number of events 2 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Cardiac disorders Atrial fibrillation	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Cardiac disorders Bradycardia	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Cardiac disorders Cardiac arrest	0.28% 2/710 • Number of events 2 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Cardiac disorders Cardiac failure congestive	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Cardiac disorders Ventricular tachycardia	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Cardiac disorders Pulseless electrical activity	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Gastrointestinal disorders Intestinal perforation	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Gastrointestinal disorders Peptic ulcer	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Gastrointestinal disorders Vomiting	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Gastrointestinal disorders Abdominal wall hematoma	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
General disorders Asthenia	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
General disorders Chest pain	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
General disorders Fatigue	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
General disorders Malaise	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Hepatobiliary disorders Hypertransaminasemia	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.28% 2/707 • Number of events 2 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Infections and infestations Appendicitis	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Infections and infestations Laryngitis	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Infections and infestations Pyelonephritis	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Infections and infestations COVID-19 pneumonia	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Injury, poisoning and procedural complications Accidental overdose	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Injury, poisoning and procedural complications Ankle fracture	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Injury, poisoning and procedural complications Gun shot wound	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Injury, poisoning and procedural complications Post procedural hemorrhage	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Injury, poisoning and procedural complications Traumatic hemothorax	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Investigations Transaminases increased	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Metabolism and nutrition disorders Failure to thrive	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Musculoskeletal and connective tissue disorders Hematoma muscle	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Nervous system disorders Migraine	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Nervous system disorders Seizure	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Nervous system disorders Syncope	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Nervous system disorders Carotid artery occlusion	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Nervous system disorders Status migrainosus	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Renal and urinary disorders Acute kidney injury	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.28% 2/707 • Number of events 2 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.42% 3/710 • Number of events 3 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.57% 4/707 • Number of events 4 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.28% 2/707 • Number of events 2 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Skin and subcutaneous tissue disorders Urticaria	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Vascular disorders Hypotension	0.28% 2/710 • Number of events 4 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Vascular disorders Dry gangrene	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Vascular disorders Deep vein thrombosis	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Vascular disorders Peripheral artery occlusion	0.14% 1/710 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.00% 0/707 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.
Vascular disorders Hypertensive urgency	0.00% 0/710 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.	0.14% 1/707 • Number of events 1 • 90 Days For Other (not including Serious) Adverse Events, only Grade 3 or 4 AEs were collected.